Labels: Barbie, Brown Shoe Co., Buster Brown, CARS, children, Shoes, Transformers, U.S. Consumer Product Safety Commission, wheels

Typical beach fun includes burrowing in the sand and burying fellow beach goers. But a new study shows that some pretty nasty bugs may lurk in the seemingly harmless sands.

The study, published in the American Journal of Epidemiology, found that kids under the age of 11 who dug in the sands were 44 percent more likely to develop diarrhea. And kids who were buried in the sand were 27 percent more likely to develop diarrhea than those who weren’t.

The study focused on 27,000 beachgoers who visited seven beaches around the country between 2003 and 2007. Three hundred and six children, or 6 percent, developed diarrhea. All of the children recovered on their own.

All of the beaches included in the study were all within seven miles of a sewage treatment plant.
However, other studies that focused on beaches far from sewage treatments plants still had high levels of E. coli and Enterococcus bacteria in the top 8 inches. In fact, levels can be almost 40 times those found in the water at the same beaches.

Beaches become contaminated from storm sewer runoff or from animal feces. Once the germs are there, the sand provides a very friendly environment for the bugs to replicate.

When the researchers looked at their data by location, they found that some beaches were far worse than others. Huntington Beach, which is on the shores of Lake Erie in Bay Village, Ohio, had no increase in the risk of diarrhea, while Fairhope Beach, which is on the shore of Mobile Bay in Fairhope, Ala., had an increase of almost 200 percent among those who dug in the sand.

Dr. Philip Kazlow, director of pediatric clinical gastroenterology at NewYork-Presbyterian Morgan Stanley Children's Hospital suggests using hand sanitizer and not ingesting the water or sand from beaches. The only way to get a gastrointestinal disease is to ingest the germs.

For more information please see: http://aje.oxfordjournals.org/cgi/content/abstract/170/2/164

Labels: Beach, children, diarrhea, Family, Sand

In a study released by the British Medical Journal, researchers found that repeated use of antibiotics to treat acute ear infections in young children increases the risk of recurrent ear infections by 20 percent.

The study included 168 children, 6 months to 2 years old, who were given antibiotics to treat an ear infection. Researchers found that 63 percent of the children who were given the antibiotic amoxicillin experienced a recurrent ear infection within three years, compared with 43 percent of children given a placebo at the time of their initial ear infection. However, the study also found that 30 percent of children in the placebo group had ear, nose, and throat surgery after their initial infection, compared with 21 percent in the amoxicillin group.

According to researchers, the higher recurrence rate among children who took amoxicillin could be due to a weakening of their body’s natural immune response as a result of taking an antibiotic at the initial stage of infection. Antibiotic use in such cases may cause an “unfavorable shift” toward the growth of resistant bacteria. Researchers say that antibiotics may reduce the length and severity of the initial ear infection, but may also result in a higher number of recurrent infections and antibiotic resistance.


For more information see: http://drugs.com/new/antibiotics-may-boost-risk-recurrent-ear-infection-18591.html

Labels: amoxicillin, antibiotics, babies, British Medical Journal, children, ear infection

The U.S. Center for Disease Control and Prevention (CDC) announced today that it plans to reinstate booster shots of the vaccine HiB (Haemphilus influenza type b) for babies and toddlers ages 12 to 15 months. The vaccine protects against bacterial meningitis.

In 2007 Merck & Company Inc. recalled its HiB vaccines due to the fact that some of the production equipment used was not properly sterilized. The CDC said that the HiB vaccine made by Sanofi Pasteur will increase enough to allow reinstatement of the HiB booster in July. However, due to the short supply of the vaccine there will not be a mass recall to administer the vaccine to older children who missed their booster, stated the CDC.

Before the introduction of the vaccine in the early 1990s, about 20,000 U.S. children would come down with illnesses caused by HiB bacteria a year. Vaccination has cut that by 99 percent, according to the CDC.
For more information see: http://www.reuters.com/article/domesticNews/idUSTRE55O3QZ20090625

Labels: bacterial meningitis, booster shots, children, HiB, vaccine

Propylthiouracil (PTU) treats hyperthyroidism (including Graves disease) by decreasing the amount of thyroid hormone produced by the thyroid gland. Its notable side effects include a risk of agranulocytosis. Agranulocytosis is a rare, drug-induced blood disorder that is characterized by a severe reduction in the number of white blood cells in the circulating blood.

Propylthiouracil is only available in the United States as a generic medication. Some manufacturers include Actavis Elizabeth, LLC of New Jersey and West-Ward Pharmaceutical Corp, also, of New Jersey.

Recently on June 3, 2009, the FDA alerted healthcare professionals of the seriousness of hepatic reactions related to PTU. It poses a risk of serious liver injury, including liver failure and death in adult and pediatric patients.

Reports to FDA’s Adverse Event Reporting System suggest there is an increased risk of hepatotoxicity with PTU when compared to methimazole. Metimazole is another treatment option for thyroid disorders. FDA has identified 32 cases (22 adult and 10 pediatric) of serious liver injury associated with PTU use. Although both PTU and Metimazole are treatments of hyperthyroidism due to Graves’ disease, healthcare professionals should carefully consider which drug to initiate in a patient recently diagnosed with Graves’ disease.

Physicians should closely monitor patients on PTU therapy for symptoms and signs of liver injury, especially during the first six months of treatment.

PTU should not be used in pediatric patients as a last resort. The FDA suggests that PTU only be used in pediatric patients who are allergic to or intolerant of Metimazole, and there are no other treatment options available.

West-Ward’s label from September 2007 does warn of agranulocytosis and of severe hepatic reactions. It is generally perceived the treatment of hyperthyroidism and not the disease itself causes these serious side effects.

Reports of adverse events associated with Propylthiouracil, including liver failure, should be reported to the FDA.


The FDA can be contacted via:
Online at www.fda.gov/medwatch/report.htm
Phone at 1-800-FDA-1088
Fax at 1-800-FDA-0178, using the MedWatch Form 3500
(available at www.fda.gov/medwatch/ getforms.htm)
Mail, using the postage-paid MedWatch Form 3500 (see above), to MedWatch, 5600
Fishers Lane, Rockville, MD 20852-9787

For more information please see: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm164162.htm

Labels: children, death, FDA, hepatic, Liver, PTU

The World Health Organization recommended that all children receive a vaccination against the rotavirus. Rotavirus is a leading cause of diarrhea which kills more than 500,000 children worldwide each year. The virus includes vomiting and diarrhea, in infants and young children, and is highly contagious. An estimated 1,600 children under the age of 5 are killed by this infection, every day, with more than 85 percent of the deaths occurring in Africa and Asia.

Dr. Paul, Offit, chief of infectious diseases at Children’s Hospital of Philadelphia and co- inventor of one of the rotavirus vaccines manufactured by Merck & Company, said “by immunizing half the children in the United States the incidents of disease will be reduced by 80 to 90 percent”.

The first vaccine developed to fight rotavirus, sold by Wyeth, was pulled from the market in 1999 after it was linked to a life-threatening type of bowel obstruction, known as intussusception. According to Merck and Company their vaccine called Rotarix, does not have this problem. Merck and Company conducted a study of more than 63,000 infants. In that study, there were no increased risks of intussusception in those who received Rotarix compared to those who received placebo. The FDA has approved the vaccine and it is currently being used to immunize children. However, the FDA has requested that the manufacturer conduct post- marketing safety studies involving more than 40,000 infants to provide additional safety information.

For more information see: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2008/ucm116875.htm

Labels: children, david carradine; rotavirus, diarrhea, infectious diseases, vaccine

Mike Tyson’s four-year-old daughter Exodus was taken off life support and pronounced dead on Tuesday. Exodus Tyson’s seven year old brother discovered her Monday hanging from a treadmill cable in the family’s home.

“Somehow she was playing on this treadmill, and there’s a cord that hangs under the console, it’s kind of a loop,” police Sergeant Andy Hill said. “Either she slipped or put her head in the loop, but it acted like a noose, and she was obviously unable to get herself out of it.”

Exodus’s mother took her daughter out of the cable, called 911 and attempted to revive her.

“There are no words to describe the tragic loss of our beloved Exodus,” the family said in a statement. “We ask you now to please respect our need at this difficult time for privacy to grieve and try to help each other heal.”

With the death of Exodus Tyson, attention should be given to the dangers of kids playing on home exercise equipment. The U.S. Consumer Product Safety Commission reported that about 8,700 children under age five- years- old are injured on exercise equipment including treadmills, each year.

This incident is a good reminder that there are hidden dangers in and around your home that you are likely overlook as a hazard to your kids.

Labels: children, dead, life support, mike tyson, treadmill

Young children are reportedly developing premature or inappropriate sexual organs from their contact with adult users of testosterone gel. Specifically, young girls developed male sex characteristics, and boys prematurely developed male sex characteristics. The FDA is now requiring two testosterone gel products to have a boxed label warning of these serious side effects.

The gels in question, AndroGel and Testim, are approved for use in men who have extremely low testosterone levels. Women reportedly use testosterone gel to increase libido; this is an off-label, non-FDA approved use of testosterone gel and not recommended. In 2007, there were 1.4 million prescriptions dispensed for AndroGel and just 370,000 for Testim.

AndroGel is manufactured by Solvay of Belgium. Testim is manufactured by Auxilium of Malvern, PA.

Dr. Dianne Murphy, director of the Office of Pediatric Therapeutics at the FDA, suggests that a gel user could have caused the child to come into contact with the gel by forgetting to wash his or her hands or the treated area. Additionally, the gel user may have not waited for skin to dry, and then picked up the child and held him or her.

Children ages 9 months to 5 years are among the eight reported cases the FDA is following. These children suffer from abnormal effects, including inappropriate enlargement of the genitalia, premature development of pubic hair, advanced bone age, increased libido and aggressive behavior.

Most of the children's signs and symptoms regressed after they were no longer exposed to the gel. However, a few children still have enlarged genitalia and bone ages higher than the child's chronological age, the FDA said.

One of these children required surgical intervention. Some children also had to undergo invasive diagnostic procedures.

More than a dozen additional reported cases are currently under review by FDA.
The current labels of the two gel products instruct users to wash their hands after use, and to cover treated skin with clothing.

When product users applied gel to body parts that were not indicated in the product's labeling, they "increased the opportunity for a child to be inadvertently exposed," Murphy said.
The FDA recommends that children and women avoid contact with the places where men have applied these products. The agency also recommends that adults who use testosterone gels always do the following:

• Wash hands with soap and water after every application.• Wash the site where the gel was applied with soap and water before coming into skin contact with another person, especially children.

• Cover the application site with clothing when gel has dried.

• Note that the use of non-FDA-approved testosterone gels that can result the same effects should be avoided.

Health care professional and consumers are urged to contact the FDA with adverse event or product quality issues with the contact information below.

--Online: www.fda.gov/MedWatch/report.htm
--Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
--Fax: (800) FDA-0178
--Phone: (800) FDA-1088

For more information please see: http://www.fda.gov/bbs/topics/NEWS/2009/NEW02011.html

Labels: AndroGel, children, FDA, libido, sex characteristic, testim, Testosterone gel, warning

Labels: baby, cancer, children, johnson, products, soap

King Midas, Inc, a California-based food distribution company, has recalled candy imported from Mexico because it contains high levels of lead. Pregnant women and children who have eaten Hola pop! Original Lollipop candy should immediately consult their doctors.

King Midas has warning stores to stop selling its caramel lollipop with a salted apricot in the center. The lollipops come in multiple fruit flavors.

Dr. Mark Horton, director of the California Department of Public Health, recently warned consumers on May 2, 2009 not to eat Hola Pop! La Original Lollipop Candy imported from Mexico after tests found unacceptable high levels of lead. The testing of the candy found that Hola Pop La Original Lollipop Candy contained as much as 0.25 parts per million of lead. California considers candies with lead levels above 0.10 parts per million to be unacceptable and contaminated.

The candy should be discarded immediately.

Consumers who find Hola Pop La Original Lollipop Candy for sale are encouraged to call the California Department of Public Health Complaint Hotline at 1-800-495-3232.

For more information about lead poisoning, please see the CDC website listed below or contact your local county childhood lead poisoning prevention program or public health department.
http://www.cdc.gov/nceh/lead/artificialturf.htm.

For more information about the recall please also see:

http://ww2.cdph.ca.gov/HealthInfo/news/Pages/NR2009-38-HolaPopLaOriginalLollipopCandy.aspx

Labels: california, children, hola pop, lead, lollipops, Mexico, poisoning, pregnant

After four years, the family of a 12 year old boy who fell off an indoor playground at a Riverside County, California Burger King received a $20 million settlement. In 2005, the now severely injured boy and his sister were playing on the playground when the boy fell smashing his head on a tile surface. A negligence lawsuit was filed against Burger King and Delta Marketing, Inc., the installer of the playground. As a result of the injury, the boy suffers from traumatic brain injury, also known as TBI. The boy also suffers from severe injury to the parietal and left front lobes of his brain as well as lung injuries. The boy has had to be hospitalized numerous times including a two month admission to Children’s Hospital in San Diego. The boy still continues rehabilitation for his severe brain injury.


Parents should examine playgrounds closely before allowing their sons or daughters to play. Prior to releasing a child to play, parents should ask: Does the playground have some sort of cushioning underneath, such as a mat? Has the playground been well maintained? If the playground is outside, parents should consider the heat of the day. In the summer, an outdoor slide or swing that has set in the scorching sun can get so hot that it can give your child severe burns.

Labels: Burger King, children, may 20, parent, playground, TBI, traumatic brain injury

On Monday, May 18, the FDA issued a class I recall for SmartMonitor 2 Infant Apnea Monitor. A class I recall is the highest recall level that can be issued and is only issued when a product has a reasonable probability of causing serious injury or death. The recalled Apnea monitor is manufactured by Respironics, a Pennsylvania based health care device manufacturer.

The SmartMonitor 2 is used by both hospitals and consumers alike. It is used as a monitoring device in order to continuously watch an infant’s breathing and heart rate. The recall was issued because the SmartMonitor2 can fail to alarm when an infant’s breathing stops or his/her heart rate drops to a dangerously low level. The models that are being recalled were manufactured between January 16, 2008 and November 13, 2008. They were distributed from January 13, 2008 to December 31, 2008. The model numbers being recalled include model 4002 and 4003. The serial numbers of the recalled models are 3000033364 through 3000038740. The FDA advises that all stop using the product immediately and to report any problems to their doctor and the FDA. Currently, there have been no recorded fatalities from this device.

More than 4,900 defective infant apnea monitors have been voluntarily recalled. The potential defect is the failure of the audible alarm, which may cause the alarm not to sound when it should. The FDA stated that on April 23, 2009 Respironics notified medical supply companies of the potential defect in the SmartMonitor 2 infant apnea monitors. Respironics wanted all monitors in the companies’ inventories retuned.
Customers with questions or concerns regarding the SmartMonitor2 infant apnea monitor recall may contact Respironics at 1-888-345-4630.The FDA requests that Health care professionals and consumers may report adverse reactions or quality problems related to the recalled infant apnea monitors to the FDA's MedWatch Adverse Event Reporting program via:
Online: www.fda.gov/MedWatch/report.htm
Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm
FAX: 1-800-FDA-0178

For more information please see: http://www.fda.gov/MedWatch/safety/2009/safety09.htm#SmartMonitor
http://www.fda.gov/cdrh/recalls/recall-042309.html

Labels: apnea, children, devices, FDA, monitor, recall